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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSJM MECHANICAL HEART VALVE, MASTER SERIES COATED AORTIC VALVED GRAFT
Classification Nameheart-valve, mechanical
Generic Namecoated aortic valved graft
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP810002
Supplement NumberS055
Date Received01/29/2001
Decision Date03/16/2001
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new manufacturing site located at steris isomedix, vega alta, puerto rico.
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